(29 days)
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS
270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS
Stated values (as determined in a steam resistometer):
30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
2.4 minutes at 134°C
1.5 minutes at 135°C
The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.
It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.
The information provided describes the acceptance criteria and study proving the Getinge Assured MI Steam Migrating Integrator meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Pre-Determined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Steam Resistometer (BIER vessel) Testing: (According to ANSI/AAMI/ISO 11140-1:2014 and FDA Guidance) | - Pass result at the stated value (SV) for each temperature claimed: - 30 Minutes at 121°C - 3.8 minutes at 132°C, 4.1 minutes at 132°C, 4.0 minutes at 132°C - 2.1 minutes at 134°C, 2.2 minutes at 134°C, 2.4 minutes at 134°C - 1.7 minutes at 135°C, 2.0 minutes at 135°C, 1.8 minutes at 135°C | PASS |
| - Failing Result at 15% less time of SV for each temperature claimed | PASS | |
| - Failing Result at 1°C less for each temperature claimed | PASS | |
| Hospital Steam Sterilizer Testing: (To demonstrate pass/fail results from an actual sterilization cycle used in a health care facility according to FDA Guidance) | - 100% samples passing under passing conditions for each cycle | PASS |
| - 100% samples failing under failing conditions for each cycle | PASS | |
| Dry Heat Testing: (According to ANSI/AAMI/ISO 11140-1:2014 and FDA Guidance) | - Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| Side-by-side testing of the biological indicator and integrator in steam resistometer: (As specified in FDA Guidance) | - The integrator does not reach its endpoint before the biological indicator is inactivated | PASS |
| Offset/Transference: (According to ANSI/AAMI/ISO 11140-1:2014) | - The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | PASS |
2. Sample size used for the test set and the data provenance:
The study involved "3 manufactured lots" of the Integrator for performance testing. The document does not specify the exact number of units or individual indicators tested within each lot for each distinct test. The data provenance is not explicitly stated as originating from a specific country, but the submission is to the U.S. FDA by a U.S.-based company (SteriTec Products Manufacturing CO INC, 74 Inverness Drive East Englewood, CO 80112 U.S.). The studies are prospective in nature, as they involve active testing of the device to verify performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of device (chemical integrator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The performance is based on physical and chemical reactions (e.g., color change, migration) under controlled conditions, compared against established standards. Therefore, information about the number or qualifications of human experts establishing ground truth for the test set is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The "ground truth" for chemical indicators like this is determined by objective physical/chemical changes against defined parameters (temperature, time, steam presence). It does not involve subjective human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a passive chemical indicator, not an algorithm or software. Its performance is inherent in its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this device's performance is established by objective criteria based on physical and chemical reactions under controlled steam sterilization conditions, defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. This includes:
- Temperature and time exposure in a steam resistometer (BIER vessel).
- Observation of indicator agent migration/color change.
- Confirmation of lack of reaction under sub-lethal conditions (e.g., 15% less time, 1°C less, dry heat).
- Comparison with biological indicators in terms of inactivation.
8. The sample size for the training set:
Not applicable. This is a physical/chemical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).